Fibromyalgia is a disease characterized by widespread musculoskeletal pain and tenderness on palpation at so called tenderpoints. The disease is diagnosed according to criteria as defined by the American College of Rheumatology (ACR) [see Arthritis and Rheumatism, Vol. 33, No. 2, pages 160-172, 1990]. In addition to pain symptoms, in the majority of fibromyalgia patients a variety of functional symptoms such as headache, insomnia, irritable bowel syndrome, sicca symptoms, increased sweating, dizziness, tremor, dyspnoea, arrhythmias, paraesthesias, headache/migraine, fatigue, psychopathological disorders and others occur. Therefore, the medical approaches towards management of fibromyalgia should not exclusively aim at relief of pain symptoms but also aim at improvements in functional symptoms.
Currently, there is a need for compositions that provide for the symptomatic relief from fibromyalgia and other diseases and disorders, believed by some within the medical community, to be related to inflammation, e.g., arthritis, osteoarthritis, herniated cervical disc, chronic fatigue syndrome, gout, rheumatoid arthritis, lupus, multiple sclerosis, neuropathic pain, irritable bowel syndrome (IBS), depression, anxiety, Sjögren's Syndrome, and Ehlers-Danlos Syndrome. These diseases and disorders can have symptoms associated with inflammation, that include, e.g., diffuse pain, jaw or facial pain, back or neck pain, muscle pain, joint pain, arthritis pain, osteoarthritis pain, pelvic pain, chest pain, neuropathic pain, vulvodynia, urethral pain, weakness, fatigue, chronic fatigue, dizziness, paresthesia, impaired cognition, sleep disturbance, joint stiffness, tendonitis, hypersensitivity to cold, hypersensitivity to sensory stimuli, photophobia, phonophobia, osmophobia, allodynia, hyperalgesia, and headache.